EMVO ON-BOARDING HOW TO CONNECT TO THE EU HUB? VERSION5.0 18 OCTOBER 2017 www.emvo-medicines.eu helpdesk@emvo-medicines.eu Please check www.emvo-medicines.eu for the latest version of this presentation and the On-boarding Guideline.
DISCLAIMER These On-boarding Guideline/Manual for MAH (without parallel distribution activity) and Parallel Distributors (MAH with parallel distribution activity) and the related Power-Point presentation (the "Guides") are provided "AS IS" by EMVO. They are provided for your information only and do not amount to professional advice or recommendations from EMVO. No warranty of any kind is made or given by EMVO with respect to these Guides or use thereof, including, but not limited to, as to the accuracy or the completeness thereof. Use of these Guides is at the your own risks and perils. To the fullest extent permitted by applicable law, EMVO expressly disclaims all warranties of any kind, whether expressed or implied, including, but not limited to the warranties for hidden or latent defect, of merchantability, fitness for a particular purpose and non-infringement. EMVO shall not be liable for any direct or indirect damage, loss or claims, including loss of use, data, profits, benefits, data, business, opportunity, goodwill, clientele, for third party s claims, or for any other indirect, special, incidental or consequential damages of any kind in connection with or arising out of the use of any information disclosed hereunder, whether alleged as a breach of contract (including grave fault), tort, negligence (including gross negligence), hidden/latent defects, strict liability or any other legal theory, even if the EMVO had been advised of the possibility of such damage. Nothing herein shall, however, operate to limit or exclude any liability for fraud or other liability that cannot be legally excluded. EMVO reserves the right to amend these Guides at any time without prior notice. 2
ON-BOARDING PARTNER PORTAL General Information How does the On-boarding work? 3
ON-BOARDING PARTNER PORTAL General Information How does the On-boarding work? 4
FMD LEGISLATION AND DELEGATED ACT Connect approx. 2,500 On-boarding Partners (OBPs) to the EU Hub Establish National Systems in 32 countries Connect many thousand Pharmacies and Wholesalers Serialise all affected pharmaceutical packs (10.5 bn) 2011 2016 2017 2018 2019 July 2011 Publication of FMD FMD: Falsified Medicines Directive 9 Feb 2016 Publication of Delegated Regulation 36 Mon 9 Feb 2019 Mandatory verification of all packs in scope ~ 474 days remain 5
RESPONSIBILITIES OF THE SUPPLY CHAIN PARTNERS Serialization by MAH Risk based verification by Wholesalers Verification and check-out at point of dispense Safety features: Code ( unique identifier ) + Tamper evidence System set up and Governance by MAH together with other stakeholders Oversight by competent authorities NMVS Product #: 09876543210982 S/N: 12345AZRQF1234567890 Batch: A1C2E3G4I5 Expiry: 140531 HUB 6
EMVO MEMBERS Pharmacies Wholesalers Hospitals Parallel Distributors Research Based Industry Generics Industry 7
ORGANISATIONAL CHART EMVO Board of Directors President: Hugh Pullen (EFPIA) Vice-President: Sonia Ruiz Morán (PGEU) Treasurer: Richard Freudenberg (EAEPC) Monika Derecque-Pois (GIRP) Adrian van den Hoven (Medicines for Europe) General Management Andreas Walter Markus Gerigk (External Consultant) Commercial & Partner Management Tobias Beer Operations Koen Van Gompel Office Management Marisa Jimenez Sanchez Quality Assurance Stephan Theunissen Fanny Trenteseaux André Geraldes NN (Legal Counsel) Paul Mills (External Consultant) Willem Theunissen (External Consultant) Lea Auriol (Intern) Kirsi Kulmakorpi (Intern) Jannik Jäger (Intern) 8
SYSTEM LANDSCAPE OBP 9
SYSTEM LANDSCAPE II OBP OBP OBP: On-boarding Partner NMVS: National Medicines Verification System NMVO: National Medicines Verification Organization 10
WHAT IS AN OBP? o OBP means On-Boarding Partner. The OBP is the contracting party of EMVO; it concludes the Participation Agreement (PA). o The OBP represents the Marketing Authorization Holders (MAH) on behalf of which it will upload data for in the European Hub. It has therefore to be legally authorized to conclude contracts on behalf of a MAH/a group of MAHs. o The OBP has to be affiliated (*) to the MAH(s) on behalf of which it will upload data in the European Hub. o The OBP should be located in the European Economic Area. o The OBP can only upload product data for: its affiliated MAHs a manufacturer as long as the marketing authorization of the related products lies within the OBP corporation. (*) Affiliate shall mean, in relation to a Party, any other person affiliated with such Party within the meaning of Article 11 of the Belgian Code of Companies (it being understood, for the avoidance of doubt, that the definition set out in said Article 11 is agreed to also apply to non-belgian persons). 11
EMVO EXAMPLE 1 EU Hub PA with EMVO Company A (Manufacturing & Marketing Authorization Holder) = On-boarding Partner (OBP) Product AS3 Product AS2 Product AS1 12
EXAMPLE 2 EMVO EU Hub Company A European headquarter = OBP (On-boarding Partner) PA with EMVO Affiliated Manufacturing & Marketing Authorization Holder Company A -ES Affiliated Manufacturing & Marketing Authorization Holder Company A -NL Affiliated Manufacturing & Marketing Authorization Holder Company A -AT Product AT1 Product NL2 Product NL1 Product ES3 Product ES2 Product ES1 13
EXAMPLE 3 EMVO EU Hub PA with EMVO Company A European headquarter = On-boarding Partner (OBP) Company B - European headquarter = On-boarding Partner (OBP) PA with EMVO Affiliated Manufacturing & Marketing Authorization Holder Company A -DE Affiliated Marketing Authorization Holder Company A -FR Affiliated Manufacturing Authorization Holder Company A -AT Affiliated Marketing Authorization Holder Company B-NL Affiliated Marketing & Manufacturing Authorization Holder Company B -AT Product AT1 Product NL3 Product NL2 Product NL1 Product FR2 Product FR1 Product DE3 Product DE2 Product DE1 The marketing authorisation holder (MAH) is legally responsible for the quality, efficacy and safety throughout the entire life cycle of the product. Activities may be delegated but overall responsibility is retained by the MAH. 14
WHAT IS AN OBP GATEWAY PROVIDER? o A third-party contractor engaged by the OBP, who assists the OBP entirely or partially with the development, the implementation, the provision, the use, and/or the operational phase related to the OBP interface to the EU Hub via a Gateway Connection, o Every OBP Gateway Provider has to be promoted by at least one OBP in the On-boarding Process, o EMVO has then to validate and approve the proposed Gateway Provider, if all requirements are fulfilled. 15
ON-BOARDING CONTRACT LANDSCAPE EMVO Participation Agreement OBP Frame Contract HUB Service Contract Solidsoft Support Contract OBP CP EMVO: Solidsoft: OBP: OBP CP: European Medicines Verification Organization IT Service Provider for implementation and operation of European HUB On-Boarding Partner IT Service Provider - Gateway connection - Direct connection 16
ON-BOARDING PROCESS Managed and administered by EMVO s Commercial & Partner Management Team 1) Participation Request 2) Contractual Onboarding 3) Legitimacy Check Collect information Initial Contact Portal registration Company Information Single Point of Contact (SPOC) Invoicing Information Participation Agreement (PA) Legitimacy check of organizations and person responsible Multi-stage procedure EMVO received Payment Managed by EMVO s Operations Team 4) Technical Onboarding System Connection System Testing System Operation 17
ON-BOARDING PARTNER PORTAL General Information How does the On-boarding work? 18
OBP PORTAL Prerequisite to on-board > 2.500 MAHs/Parallel Distributors User-friendly web-based portal Decrease EMVO s response time Starting point/ trigger for legitimacy check 19
HOW DOES THE ON-BOARDING WORK? On-boarding Partner Portal (Support software to guide the OBPs through the requirements to connect to the EU Hub) 20
HOW TO SPEED UP THE PROCESS RIGHT FROM THE START? Collect Information: 1. Visit EMVO Download Section https://emvomedicines.eu/downloads/ 2. Visit EMVO Knowledge Data Base https://emvomedicines.eu/faq/ 3. Who will be the On-Boarding Partner? 4. What is my Company Registration number and VAT number? 5. Who can and will be the Authorized Representative? 6. Who can and will be the Single Point of Contact? 7. How many MAHs does the OBP represent? 21
HOW TO REQUEST TO PARTICIPATE 1. Via website link 2. Fill in User + Company details 3. You ll be directed to the confirmation screen 4. Check your email to validate your account 22
HOW TO REQUEST TO PARTICIPATE 5. Your company portal will be created 6. Your company portal is created 7. Follow the instructions in your email to login to your Company portal 8. Your Company portal is ready to On board 23
INITIAL REGISTRATION REQUESTER CREDENTIALS IMPORTANT NOTE! The SPOC is the only person having the credentials to access the portal. However, in the event the Initial Registration Requester is the same person as the SPOC, s/he will be able to access the portal with the credential received in the first place. 24
ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 25
STEP 1: PROVIDE INITIAL INFORMATION Trigger step 1: Successful Request to Participate To add or modify the requested information Estimated time to complete Status: Not Started In Progress Complete 26
1.1 COMPANY INFORMATION Company name make sure to provide the full official name of your company Company identification numbers: VAT and Company registration number make sure not to get confused between the OBP company, the parent company, and the MAHs information. make sure to include the full sequence of digits, no typo, and the initial country identification letters in front, if necessary Country name / Country of registration make sure to provide the Country name, not the one of the county 27
1.2 AUTHORISED REPRESENTATIVE Please provide the information related to the Authorised Representative together with a copy of proof attesting of the authorisation of that person to sign on behalf of the company. Note 1: The Authorised Representative (AR) is the person authorised to sign on behalf of the company. The AR will sign the Participation Agreement. Mandatory in order to proceed with the further steps Note 2: A document listing all the National Registers in Europe where to find the relevant copy of proof for your company is available on our website in its download section. 28
FRENQUENTLY COMMITTED ERRORS Copy of proof of the Authorised Representative Purpose: check the authorisation of your named Authorised Representative (AR) to sign on behalf of the company An official register (please consult the National Registers list for european countries on our website: https://emvo-medicines.eu/wpcontent/uploads/2017/06/national-registers-for-obtaining-the-copy-of-proof.pdf ) The AR is to be explicitly named in the official register together with his/her senior management position and/or his/her explicit authorization Validity of the document with respect to a potential expiration date 29
1.3 CONNECTION PROVIDER INFORMATION Optional step: If the choice is already made concerning which type of connection will be used in order to connect to the European Hub, this field may be filled-in to provide this information and allow EMVO to start the On-boarding of the service provider in parallel. Drop-down menu listing the Certified * Gateway Providers. Making use of a certified Gateway Provider allows the OBP to start immediately a minicertification test in the Integrated Quality Environment (IQE). Note: Only two connections are allowed per OBP. * Certified Gateway Provider is a provider which for a first OBP already passed the full certification test of the Gateway of this Gateway Provider 30
ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 31
STEP 2: DETAILED INFORMATION AND PARTICIPATION AGREEMENT Trigger step 2: Successful Initial Information and Authorise Representative copy of proof Download General Info Pack Status: Not Started Completed View and Download prefilled Participation Agreement (PA) Status: Not Started Awaiting Approval Approved Rejected A sample of the PA is available on our website in its download section. Status: Not Started Completed 32
2.1 GENERAL INFO PACK In that documentation you will find the explanation of each step on the portal and the corresponding requirements as well as a user manual for the EMVO Gateway. 33
2.2 SINGLE POINT OF CONTACT Note 1: The SPOC details will be listed in the PA. By signing the PA, the Authorised Representative will confirm the SPOC appointement. The SPOC will be the responsible for providing all the required information in the OBP Portal. When the SPOC contact details will be listed, s/he will receive credentials via e-mail. At the moment of his/her first login in the portal, the initial Registration Requester s credentials will be revoked. If the SPOC is the same person as the Initial Registration Requester, (s)he will be able to access the Portal with the credentials received in the first place. Action: A prefilled Participation Agreement will be generated Note 2: The second SPOC contact details are optional. They will be used in case the first SPOC is not available. The second SPOC will not receive credentials. 34
OBP CONTRACT WITH EMVO The Participation Agreement (PA) Contractual framework for participation in the On-boarding project, e.g. Use of the EMVO Gateway Interface development Connect to the HUB SDK Includes a Non-Disclosure Agreement covering the provision of Confidential Information by EMVO, e.g on European Hub EMVO Gateway Purpose: Execution of Technical On-Boarding 35
OBP CONTRACT WITH EMVO The Participation Agreement (PA) Contractual framework for participation in the On-boarding project, e.g. Use of Gateway Interface NO development Connect to the HUB SDK CONTRACT Includes a Non-Disclosure Agreement covering the provision of Confidential Information by EMVO, e.g on NEGOTIATON European Hub Gateway Purpose: Execution of Technical On-Boarding 36
FRENQUENTLY COMMITTED ERRORS Contracts Consistency between the named Authorised Representative in step 1.2. and the person that actually signed the contracts No ammendments Two (2) hardcopies have to be sent to EMVO via post Both hardcopies are signed and both are original versions (not scanned) 37
ON-BOARDING FEE One-Time Fee per OBP 38
2.5 INVOICING INFORMATION Mandatory fields In Number of MAHs the OBP has to chose from a drop-down menu the total number of MAHs it will upload data for in the European Hub. Note: A sample of this document is available on our website in its download section. 39
2.7 MAH AND PRODUCT INFORMATION Note 1: New item allows the OBP to add a new MAH into the list. Edit allows the OBP to copy paste an excel sheet with all its MAHs listed, using the exact same name and location of the columns as shown in that section. Note 2: For the purpose of the Legitimacy Check the OBP has to provide a minimum of one MAH and a minimum of one corresponding product information. In the end, the OBP will have to fill-in the whole list of MAHs for which it will upload data in the European Hub. 40
2.7 MAH AND PRODUCT INFORMATION Note: Product information; The Marketing Authorisation Number is the licensed number related to the number of the product that the MAH received when applying for Marketing Authorisation The Marketing Authorisation Name; together with the name, please mention the strength and the pack size of the product in order to allow EMVO to identify the exact product presentation linked to the Marketing Autorisation Number. The Marketing Authorisation Registration refers to the country covered by the marketing authorization and may be centralized. 41
2.8 CONFIRM ALL INPUTTED INFORMATION By clicking on the Confirm button the SPOC confirms the accuracy of the information provided on the portal. 42
ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 43
STEP 3: APPROVALS Trigger step 3: Step 2 completed and confirm button pressed. Status: Not Started Passed Failed Status: Not Started Awaiting hardcopy Sent back on xx:xx:xxxx Status: No Status Awaiting payment Payment received 44
STEP 3: APPROVALS Note 1: The outcome of the Legitimacy Check will be communicated to the OBP s SPOC via e-mail. In the event that the Legitimacy Check outcome is not successful the OBP will have the possibility to modify the information provided. Note 2: If and only if the Legitimacy Check outcome is successful, the Participation Agreement will be countersigned by EMVO and one hardcopy will be sent back to the OBP by post. Please note that EMVO is going to check the reception of the payment and update those status every two weeks. Note 3: Only when the Legitimacy Check is successful and the payment of the On-boarding fee has been received, the OBP will be granted access to the Technical Onboarding. 45
ON-BOARDING PARTNER PORTAL Step 1: Provide Initial Information Step 2: Participation Agreement + Detailed information Step 3: Approvals Step 4: Technical On Boarding 46
STEP 4: TECHNICAL ON-BOARDING Trigger step 4: Step 3 completed Note: If you make use of a Gateway Connection, step 4.2.2 (ITE) is optional Status: Not Started Completed Status: Not started Completed Access sub-steps Access sub-steps 47
4.1 TECHNICAL INFO PACK The Technical Info Pack contains the following information in their last available versions: 1. Documentation.NET.Net Callback Service.Net Hub 2.0 SDK EMVS0794 - EMVS OBPs.NET SDK Installation Guide 2. Documentation JAVA EMVS0787 - EMVS Java SDK Installation Instructions For OBPs EMVS Java SDK_MAH_Hub_2 3. On Boarding Steps EMVO_0077_OBP On-boarding Guideline EMVO_0086_OBP On-Boarding Presentation EMVO_0117_Creating CSR Files EMVS0714 - EMVS SDK for OBPs EMVS0789 - EMVS SDK Quick Start Guide For OBPs 48
4.2.1 CONNECTION DETAILS Note: This step is pre filled if you completed step 1.3 Drop-down menu listing the Registered * Gateway Providers. Making use of a Registered Gateway Provider allows the OBP to start immediately a selfcertification test in the Integrated Quality Environment (IQE). * Registered Gateway Provider is a provider which signed the License Agreement with EMVO and a Support Contract with SolidSoft. 49
4.2.2 ITE Note: For Gateway Connections, step 4.2.2 (ITE) is optional - Organisation name - Company Type - Organization ID - Client ID Upload the generated CSR file corresponding with information provided on step 4.2.2.1 Status: Not required No Status Failed Available Status: Not required No Status Failed Complete Download Client and Hub Certificates to have access to ITE. Check Service Endpoints Optional: Check Test Results After completing Step 4.2.2.3 a Session Token request will automatically be triggered. Status: Not required No Status Failed Available Downloaded on xx:xx:xxxx 50
4.2.3 IQE Note: When the OBP is confident that its interface is ready for testing, (s)he can start testing in IQE Info button will display the current Session Token Test Status Metrics and Submission for Approval 51
4.2.2.5 IQE - TEST STATUS METRICS This will send the current Test Results for EMVO s approval. If everything is fine EMVO will allow access to PRD. Note: The OBP should verify and submit the Test Results of all positive transactions which are sent to the EU Hub for the last 30 minutes and will cover the basic requirements. In the current version of the EU Hub SR 1.3, Batch Recall and Acknowledgments can be skipped as these functions are not implemented yet. When all basic transactions are passed, OBP should click the Submit button. 52
4.2.4 PRD Note: We only allow validated systems to connect to the Production environment. It is a prerequisite to have an approved test result. 53
4.3 CONNECTION 2 Optional: This step can be used in case the OBP wants a second connection to the EU Hub. Repeat previous steps. 54